Kornimate/medical-research-clean huggingface dataset:
system accuracy of 14 blood glucose monitoring systems

Conditions: Diabetes

Summary: the system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with din en iso 15197:2015 over thr courese of 24 months


Eligibility criteria:
inclusion criteria: * male or female patients with hypo-, eu- or hyperglycaemia * the written informed consent had to be signed * the volunteers must be older than 18 years * the volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved exclusion criteria: * pregnancy or lactation * acute or chronic diseases with the risk of aggravation by the measure * a current constitution that does not allow participating in the study * participation in another study or activity with the blood glucose measuring system evaluated in the present study * application of substances listed in appendix a of din en iso 15197:2015
lympha procedure for the prevention of lymphedema after axillary lymphadenectomy

Conditions: Lymphedema, Breast Cancer; Lymphedema

Summary: lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. the purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life


Eligibility criteria:
inclusion criteria: * ages 18 to 75 years (inclusive) * patients undergoing unilateral or bilateral breast cancer related axillary lymphadenectomy * free of distant metastasis in preoperative screening * histology results of axillary lymph nodes could be either negative or positive * patients who undergo preoperative chemotherapy can be included * willingness and ability to provide written informed consent * willingness and ability to comply with all study procedures exclusion criteria: * primary lymphedema of the affected upper limb * secondary lymphedema of the affected limb prior to the lymphadenectomy * radiotherapy at the axilla before the study / surgery * allergic reaction to porcine collagen or icg * receiving radiation therapy to the involved nodal basin in a period less than 4 weeks after the surgery * concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening * other medical condition that could lead to limb edema, such as (but not limited to primary lymphedema or acute venous thrombosis * other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion) * either of the following, at the time of baseline evaluation: ipsilateral:contralateral limb volume ratio\>1.1 or r0 bioimpedance ratio \> 1.106 when the nondominant limb is at risk, and 1.134 when the dominant limb is at risk. * life expectancy \< 2 years for any reason * pregnancy or nursing * substance abuse (such as alcohol or drug abuse) within 6 months prior to screening * severe psychiatric disease * significant or chronic renal insufficiency (defined as serum creatinine \> 2.5 mg/dl or an estimated glomerular filtration rate \[egfr\] \< 30 ml/min at screening) or requires dialytic support * hepatic dysfunction, defined as alanine transaminase (alt) or aspartate transaminase (ast) levels \> 3 × upper limit of the normal range (uln) and/or bilirubin level \> 2 × uln at screening * absolute neutrophil count \< 1500 mm3 at screening * hemoglobin concentration \< 9 g/dl at screening * any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study
study of adverse effects occuring in patients receiving an antibiotic treatment with temocillin

Conditions: Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin

Summary: the temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. the investigators wish to study the responsibility of temocillin in the occurrence of adverse effects in patients in the hospital of amiens receiving a treatment containing this molecule.

the study "continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumoniae: stability, compatibility, population pharmacokinetic studies and breakpoint selection, r. de jongh, et al, 2007 ", the author states that no adverse effects were found following injection of temocillin. in the study "temocillin use in england: clinical and microbiological efficacies in infections caused by extentedspectrum and / or derepressed ampc β-lactamase-producing enterobacteriaceae, i. balakrishnan, et al, 2011, the author faced two cases of clostridium difficile with a positive toxin test. the first patient received three doses of amoxicillin / clavulanic acid followed by one week's treatment with temocillin. this one has developed clostridium difficile diarrhea on the last day of antibiotic treatment. the second patient did not not received temocillin in the 6 weeks prior to diarrhea but received 8 days of meropenem just before this diarrhea. in all cases, temocillin can not be clearly attributed to this adverse effect and no patient developed pseudomembranous colitis.

Eligibility criteria:
inclusion criteria: * documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to temocillin exclusion criteria: * history of hypersensitivity to betalactamines (rash,...) * patient participating in another biomedical research on a drug to avoid the risk of interactions drug * grafted patient * immunocompromised patient * dialysis patient (except hemodialysis patient and dialysis patient peritoneal)
enhanced consent for symptom provocation research

Conditions: Trauma

Summary: the overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. the investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (sdi). the design includes comparing participants in a consent as usual group to participants in an enhanced consent group to see which minimizes unfavorable effects of participating in a research provocation study. in addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during sdi, and unfavorable reactions to participation in symptom provocation research.

the overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. the investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (sdi). the design includes comparing participants with and without posttraumatic stress disorder (ptsd) in a consent as usual group to participants in an enhanced consent group to see which group minimizes unfavorable effects of participating in a research provocation study. in addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during sdi, and unfavorable reactions to participation in symptom provocation research.

Eligibility criteria:
inclusion criteria: * nonsmoker * female * between 18-55 * experienced trauma * willing to have a brain scan * provide consent exclusion criteria: * alcohol abuse or dependence * bipolar disorder * suicidal intent * metal in the body or anything else that would interfere with an mri * claustrophobia or inability to lie still for 45 minutes * receiving current counseling * on certain antidepressants, benzodiazepines, or other psychotropic medication * pregnant or nursing

Keywords: trauma abuse domestic violence rape assault mri
the effect of related blood markers on diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy.

this is a multi-center(about five), randomized, double-blind, placebo-controlled clinical trial with over 1000 subjects.clinical data were collected by consulting the patient's electronic history. the data included demographic information, blood biochemical markers and electromyography. all participants provided their written informed consent to participate in this study.the study protocol was approved by the ethics committee of the first affiliated hospital of wenzhou medical university(ky-2022-r009).

Eligibility criteria:
inclusion criteria: * patients who had undergone nerve conduction examination by electromyography(emg). exclusion criteria: * pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections; * patients with alcohol abuse; history of autoimmune liver disease, liver disease or abnormal liver function at baseline; * parathyroid diseases (including hyperthyroidism and hypothyroidism); * pancreatitis, pancreatectomy or any transplant; * patients with malignancy and any serious concomitant disease limit the existence of life expectancy

Keywords: diabetic peripheral neuropathy electromyography blood parameters
lung transplantation in chronic hcv infection with post transplant epclusa treatment

Conditions: Hepatitis C, Chronic; Lung Transplant

Summary: the purpose of this study is to evaluate whether treatment with epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis c infection is feasible, safe and effective at curing hcv.


Eligibility criteria:
inclusion criteria: * hcv rna \>= 10\^3 iu/ml at screening * chronic hcv infection, defined as positive hcv antibody and/or hcv rna more than 6 months prior to screening * hcv genotype 1, 2, 3, 4, 5 or 6 * otherwise eligible for lung transplant at study site exclusion criteria: * age \<18 * treatment with any of the following agents: * amiodarone. subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 sof/vel * carbamazepine, phenytoin, phenobarbital, oxcarbazepine * rifabutin, rifampin or rifapentine * hiv regimens containing tenofovir or tipranavir/ritonavir * st john's wort * ppis, including: omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole * modafinil * have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance * hepatitis b surface antigen positive * history of hepatic encephalopathy or variceal hemorrhage * abnormal hematological and biochemical parameters, including: * hemoglobin \<8g/dl * platelets \<= 50,000/mm\^3 * alt (alanine aminotransferase), ast (aspartase aminotransferase) or alkaline phosphatase \>=10 times uln * total bilirubin \>3mg/dl * severe renal impairment, ie creatinine clearance (crcl) \<30ml/min * pregnant women or women planning to become pregnant * women or are breastfeeding * active or recent history (\<=1 year) of drug or alcohol abuse
anthropometric, metabolic, cardiovascular and symptomatic profile in postmenopausal women

Conditions: Postmenopausal Disorder

Summary: the purpose of this study is to investigate anthropometric, metabolic, cardiovascular and symptomatic profiles in postmenopausal women.

when aging, the body composition changes, leading to a reduction of muscle mass and strength, and to an increase in total body fat. these body composition changes have especially been observed in postmenopausal women, due to the hormonal changes taking place. after the menopause, the gynoid fat distribution with fat deposits in the gluteo-femoral region changes to an android fat distribution with an increased upper body fat, especially in the abdominal region. these consequences of the menopause associated with a decrease in aerobic capacity and reduced total energy expenditure may lead to the metabolic syndrome (mets). the aim of this study was to investigate the anthropometric, metabolic, cardiovascular and symptomatic profile in gynoid and android postmenopausal women.

Eligibility criteria:
inclusion criteria: * postmenopausal women * caucasian * 50-60 years of age exclusion criteria: * neurological disease * pulmonary disease * cardiac disease * oncological disease * musculotendinous or articular injuries * hormone replacement therapy * cigarette smoking

Keywords: postmenopausal women body composition metabolic syndrome menopause symptoms
impact of bluetooth haptics device distraction on mechanical pain thresholds induced by pinprick stimulators

Conditions: Pain; Anxiety

Summary: this is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli.


Eligibility criteria:
inclusion criteria: * greater than 18 years of age * english speaking * hearing intact exclusion criteria: * history of chronic pain or acute pain syndromes * currently has nausea * has hearing loss * is pregnant * is currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications

Keywords: vibrating device
register for patients with diabetic foot syndrome and critical limb ischemia

Conditions: Type 2 Diabetes Mellitus; Diabetic Foot; Critical Limb Ischemia

Summary: diabetic foot syndrome (dfs) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding increase in the risk for infections. results from clinical trials about the efficacy of interventions aimed at reducing the number of patient-relevant end points are of limited comparability due to the heterogenity of patient characteristics. by their very nature, randomized clinical trials (rct) can only focus on a limited section of the wide range of possible intervention regimes. in clinical practice, however, a number of patients with dfs will never have been part of a clinical trial. furthermore, there are only very few contemporary registers for this indication from which conclusions with regard to the comparative merits of different therapeutic strategies may be drawn. the register was conceived to find out to which extent rct patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. an rct to assess the efficacy of urokinase versus placebo is imbedded in the register.

august-1 is a register to find out to which extent rct patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. an rct to assess the efficacy of urokinase versus placebo is imbedded in the register.

Eligibility criteria:
inclusion criteria: * diabetic patients with dfs and critical limb ischemia * age 18 and older exclusion criteria: * less than 1 year life expectancy * prior major amputation * planned major expectation * prior treatment of the current episode of dfs with urokinase * mechanical heart valve replacement * cerebral event with changes in ct during the last three months * non-remediated proliferating retinopathy * uncontrolled hypertension (systolic \> 180 mmhg, diastolic \> 100 mmhg) * hemorrhagic diathesis (spontaneous quick value \ 40 sec, thrombocytes \< 100 gpt/l) * acute gastrointestinal bleeding or ulcers during the last 4 weeks * prior reverse bypass operation * concomitant participation in other clinical trials * insufficient compliance * premenopausal women not using a safe method of contraception (i. e. iud, hormone implants, hormone depot injection, combined pill (estrogens and gestagens), vaginal ring or vasectomized partner).
the efficacy of different immobilization times after achilles tendon rupture surgery

Conditions: Achilles Tendon Rupture

Summary: this study is a prospective randomized controlled clinical study. after the achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups.

this prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilization times by dividing the patients into four groups-a, b, c, and d-based on the amount of immobilization time (0, 2, 4, and 6 weeks, respectively) that include a similar rehabilitation protocol. the inclusion criteria are patients with an acute closed single-legged complete achilles tendon rupture, and an age of 18 to 60 years. the exclusion criteria are patients with prior achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. all patients will be treated surgically with the same suture technique and undergo a similar rehabilitation protocol after the brace is removed.

Eligibility criteria:
inclusion criteria: * acute closed single-legged complete achilles tendon rupture * age of 18 to 60 years. exclusion criteria: * patients with prior achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). * an inability to complete our suture technique (e.g., the distance from the rupture site to the achilles tendon insertion was less than 3.5 cm) * those without rehabilitation or follow-up outcomes.

Keywords: immobilization duration open surgery early rehabilitation
prommo trial: oral misoprostol vs iv oxytocin

Conditions: Premature Rupture of Membrane; Induction of Labor Affected Fetus / Newborn

Summary: this is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical bishop score. the study will compare oral misoprostol and intravenous oxytocin.

the purpose of this study is to look at optimal induction management of prelabor rupture of membranes (prom) at or beyond 34 weeks gestational age. objective 1: to determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin. hypothesis: cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix. sub objective 1: to determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with prom. hypothesis: misoprostol use will result in significantly lower rate of postpartum hemorrhage. sub objective 2: to evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prom. hypothesis: the use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate. sub objective 3: to analyze patient satisfaction surveys. hypothesis: patients in the oral misoprostol group will be more satisfied with their labor experience. exploratory outcome to determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin. hypothesis: the use of oral misoprostol will be cost effective in women presenting with prom and an unfavorable cervix.

Eligibility criteria:
inclusion criteria: * early term to late term pregnancy (\>37 weeks and 0 days and \<42 weeks and 0 days) * late preterm pregnancy (34 weeks and 0 days and \<37 weeks) * confirmed rupture of membranes by either sterile speculum exam or amnisure * simplified bishop score ≤ 6 * maternal age \> 18 years old * singleton gestation * appropriate gestational age dating by certain lmp or ultrasound performed prior to 20 weeks gestational age exclusion criteria: * concern for intra-amniotic infection * previous cesarean delivery * lack of appropriate dating criteria for the pregnancy * inability to give informed consent in the patient's native language * known bleeding disorder such as von willebrand's disease or hemophilia * anticoagulation administration within 24 hours of delivery